|Publication number||US7699168 B2|
|Application number||US 11/254,510|
|Publication date||Apr 20, 2010|
|Filing date||Oct 20, 2005|
|Priority date||Oct 29, 2004|
|Also published as||US20060113207|
|Publication number||11254510, 254510, US 7699168 B2, US 7699168B2, US-B2-7699168, US7699168 B2, US7699168B2|
|Inventors||Timothy R. Ryan, Cathy A. Bergin|
|Original Assignee||Medtronic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (14), Referenced by (13), Classifications (8), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. provisional application No. 60/623,484, filed Oct. 29, 2004, the entire contents of which are herein incorporated by reference.
The present invention relates to a system and apparatus for packaging replacement heart valves and the like for storing and shipping after manufacturing. More particularly, the present invention relates to a heart valve retainer for holding a replacement heart valve in a controlled and sterile condition. The present invention also relates to an apparatus from which the surgical personnel can remove the prosthetic heart valve quickly and effectively for use in a patient during heart valve surgery.
Heart valves and more specifically prosthetic aortic and mitral valves are manufactured and prepared for insertion into patients during a surgical procedure. The valves must be sterilized after manufacture and stored in a container for shipment to a hospital or surgery center. The valve is then removed from the package, rinsed and prepared for placement in a patient during surgery.
The container preserves the sterile condition of the valve, protects the valve from damage and minimizes the effort needed by the surgical team to prepare and insert the valve. Sterilization is critical and challenging in working with prosthetic devices. The devices are made in a non-sterile environment and sterilized before packaging and shipping. The valve is usually stored in a sterile solution such as a 0.2% Glutaraldehyde solution after sterilization. Glass jars are commonly used because glass resists reacting with the solution, is inexpensive and can withstand sterilization. A retainer holds the valve in a fixed position inside the container to keep it submerged in the solution.
Prior art designs to store and ship prosthetic heart valves include U.S. Pat. No. 4,750,619 to Cohen assigned to Osteonics Corp entitled “PACKAGE WITH TRAY FOR SECURING AND PRESENTING A STERILE PROSTHETIC IMPLANT ELEMENT”. In the '619 patent, a package for holding the prosthetic heart valve has a tray which is stored in a hinged receptacle which is sealed to protect against contamination. In all, three containers are used including the sealing cover. In the Dohm U.S. Pat. No. 5,720,391, entitled “PACKAGING HOLDER FOR HEART VALVE PROSTHESIS”, the prosthetic is mounted on a holder having a post. The holder is suspended in a plurality of trays each having a lid. The trays are heat sealed to protect the valve. In U.S. Pat. No. 5,823,342 to Caudillo for “PACKAGING FOR MITRAL OR AORTIC HEART VLAVE DEVICE” an outer shell is screwed together to form a housing over a container having an interchangeable holder for an aortic or mitral valve. U.S. Pat. No. 5,960,956, entitled, “STORAGE CONTAINER”, describes a container for holding a prosthetic device in a high humidity environment of sterile liquid but not submersing the device.
Manufacturers are making a variety of valve designs and sizes. This variety of size and configuration demands a flexible packaging system to reduce inventory of valve containers and retainers. Accordingly, there is a need for a system or apparatus for packaging prosthetic heart valves that can be configured to different valve designs, valve sizes, and styles with minimal changes. There is also a need for a storage system that is easy to open.
This invention relates to a novel valve retainer system and apparatus that is flexible in adapting to different valve configurations and sizes. The present invention provides an apparatus for securing a prosthetic valve in a fixed position by suspending a valve pocket in a jar filled with a sterile liquid. The present invention relates to a valve retainer having a body, a shelf and a cap. The body is a generally cylindrical structure with a first end in the jar and a second end adjacent the lid and a ledge supported between the first end and the second end. A shelf is selected having a valve pocket designed for a particular valve size and configuration. The shelf is attached to the body. The valve is placed in the valve pocket in the shelf. The valve and leaflets are protected against damage by being contained in the valve pocket. The cap is inserted into the second end of the body to engage and hold the valve securely in the pocket.
In one embodiment, the present invention comprises an apparatus that facilitates removing the valve from the package and draining away the sterile solution without touching the valve.
Preferably, the present invention comprises a container that is easy to open.
In a preferred embodiment, the invention comprises an apparatus for minimizing inventory required to package prosthetic valves for shipment, sterilization and storage by a configurable storage system.
In another aspect, the present invention provides a packaging system for prosthetic valves that is easy to assemble.
In another aspect, the present invention comprises an apparatus that minimizes exposure to non-sterile surfaces during removal to help maintain the sterile condition of the prosthetic device.
In another embodiment, the present invention is a retainer for holding a sterilized prosthetic valve that is stored in a sealed container and is conveniently removed to hold the valve for rinsing.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
The FIGS are not necessarily to scale.
The present invention provides a solution to packaging a prosthetic device in a sterile condition for shipment and storage prior to application to a patient.
A first fill hole 28 is formed in the lid 12 to provide access through the top 14 into the storage chamber 30 (
The jar 56 has a sidewall 64, an open top 66 and a closed bottom 68 forming an open cylinder shaped storage chamber 30 sealed with the lid 12. The lid 12 is removably attached to the open top 66. The storage chamber 30 has an axis 72 (
The first and second perforated strips 51, 52 have the perforation 60 aligned with the bottom edge 62 of the lid 12. Referring to
The upper wall 114 has a lock guide 121 formed therein for engaging the cap 84 and guiding the cap 84 to a locked position. The lock guide 121 has a cam surface 122 formed at an angle to the ledge 110 to guide the cap 84 toward the ledge 110 and into a locked position 115 (
Preferably, the present invention includes indicia or identification means for the valves. In the embodiment of
The outer flange 152 has inner edge 165 on the outside 158 of the support ring 150, a top 151 and a bottom 153. The outer flange 152 extends outwardly from the support ring 150. The outer flange 152 is disposed between the valve pocket 189 and the jar 56. The outer flange 152 has a plurality of drain holes 160 formed therein by drilling or molding. Each drain hole 160 has a periphery 163 defined by the edge of the drain hole 160. The drain holes 160 extend from the top 151 to the bottom 153 of the outer flange 152.
Continuing to refer to
A locating tab 164 extends from the outer edge 166 of the outer flange 152. The locating tab 164 is sized to slidably fit in the locating slot 124 in the upper wall 114 of the body 82. A plurality of snap fingers 168 are formed along the outer edge 166. The snap fingers 168 have a standoff 170 and a latch 172. The latch 172 is spaced from the bottom 153 of the outer flange 152. The snap fingers 168 are made of a resilient material such as PVC or other plastic compounds and may be molded as part of the shelf.
A larger size aortic valve configuration shelf 80 is shown in
An alternate preferred embodiment is shown in
The inside 156 of the support ring 150 defines the valve pocket 189 for containing the portion of the valve 69 a hanging below the outer flange 152. The mitral valve 69 a (
A larger size version of the mitral configuration shelf 80 a of
The valve positioner 204 is attached to and spaced from the shell 190. The handle 192 has a first end 196 attached to the inside of the shell 190. The valve positioner 204 comprises a retaining ring 206 and a locating peg 208. The locating peg 208 has end 210 on the peg 208. The valve positioner 204 appends from the handle 192 to encircle and capture the handle adapter 76 (
The shelf is attached to the ledge 110 by the snap fingers 168 and the locating tab 164. The sewing ring 74 is on the inner flange 154. The valve 69 is surrounded by the support ring 150. The handle adapter 79 is oriented toward the lid end 116 to engage the cap 84 and facilitate insertion of the handle 212 for removing the valve 69 from the retainer. The leaflets 149 of the valve 69 are shown in aortic configuration positioned above the sewing ring 74. The cap 84 is concentrically inserted into the body at the second lid end 116. The cap engages the valve 69 at valve holder 75 with the valve positioner 204 (
The handle 192 is used to move the retainer 70 in and out of the jar 56. The sterilizing solution 73 drains through the drain holes 160, 184. After removal from the jar 56, the retainer 70 may be used to hold the valve 69 outside of the jar prior to rinsing. The handle 192 is turned a quarter turn to unlock the cap 84 from the body 82. The cap 84 is removed from the body 82. The valve handle 212 is screwed into the handle adapter 79. The valve 69 is removed from the system to be prepared for use.
The shelf 80 a is attached to the ledge 110 by the snap fingers 168 and the locating tab 164. The sewing ring 74 is on the outer flange 152. The leaflets 149 a of the valve 69 a are shown in mitral configuration positioned below the sewing ring 74, away from the valve holder 75. The valve 69 a is surrounded by the support ring 150 having the leaflets 149 a extending toward the base 108. The handle adapter 79 is oriented toward the lid end 116 to engage the cap 84 and facilitate insertion of the handle 212 for removing the valve 69 a from the retainer 70. The cap 84 is concentrically inserted into the body 82 at the lid end 116. The cap 84 engages the valve holder 75 with the valve positioner 204. The mitral valve 69 a is held between the shelf 80 and the cap 84. The retainer 70 having the valve 69 a inside is placed in the jar 56.
In use, the valve 69 is manufactured having a sewing ring 74 circumferentially attached. A valve holder 75 is removably attached to the sewing ring 74. The valve 69 is sterilized. The appropriate shelf 80 is selected and sterilized with the body 82, cap 84, jar 56 and lid 12. The shelf 80 is inserted into the body 82 having the locating tab 164 in the slot 124 and the snap fingers 168 on the ledge 110. The valve 69 is placed in the valve pocket 189 resting on the sewing ring 74 and oriented with the handle adapter 796 toward the lid end 116 of the body 82. The cap 84 is concentrically inserted into the body 82 having the valve 69 between the shelf 80 and the cap 84. The handle adapter 79 is adjusted to engage the valve positioner 204 and the cap is turned to lock the cap 84 into the body 82.
The retainer 70 having the valve 69 contained therein is placed in the jar 56 and the lid 12 is attached. The sterilized solution is dispensed into the jar through one or more fill holes 28, 44 to prevent spilling or splashing on a sealing surface of the lid 12 or the jar 56. The respective tab 32, 46 adjacent each fill hole is bent over to cover the fill hole and is ultrasonically welded to the lid 12 to seal the fill hole. The tamper evident seal 50 is attached over the jar 56 and the lid 12.
The apparatus 10 with the valve 69 therein is shipped to a facility for use in a patient. The jar 56 is removed from the box and the outside of the jar 56 may be sterilized. The surgery worker grasps the jar 156 and applies an opening force (A) to a flat on the grip surface 18. The tamper evident seal tears at the perforations 60 and the lid 12 is unscrewed from the jar 56. The retainer 70 is removed from the jar allowing the sterilizing fluid 73 to drain through the drain holes 160, 184. The valve 69 may be rinsed while held in the retainer 70.
The worker grasps the body 82 and the cap handle 192 and turns the cap handle 192 with respect to the body 82. The cap 84 releases from the body 82 and is removed. A valve handle 212 is attached to the handle adapter 79. The valve 69 is removed from the retainer 70 attached to the handle 212 and further rinsed and prepared for use.
It will be appreciated that the present invention is suitable for use with a variety of different types of valves such as aortic, tricuspid, pulmonic or mitral valves. The valve is preferably oriented in the jar retainer so that the handle can be conveniently attached directly to the valve holder, without having to re-orient the valve. This minimizes the chance for valve contamination during preparation for surgical implantation.
Although the invention has been described above in connection with particular embodiments and examples, it will be appreciated by those skilled in the art that the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.
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|U.S. Classification||206/438, 623/2.1|
|International Classification||A61F2/24, A61B19/02|
|Cooperative Classification||A61F2/24, A61F2/0095|
|European Classification||A61F2/24, A61F2/00P|
|Feb 13, 2006||AS||Assignment|
Owner name: MEDTRONIC, INC.,MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:RYAN, TIMOTHY R.;BERGIN, CATHY A.;REEL/FRAME:017548/0824
Effective date: 20060207
|Oct 21, 2013||FPAY||Fee payment|
Year of fee payment: 4